Federal Circuit Review - Issue 233
Troutman Sanders LLP
233-1. Federal Circuit Finds Error in Board Conflating “Corresponding Structure” in the Specification with “Sufficiently Definite Structure”; Holds the Term Is Governed by § 112, ¶ 6
The Federal Circuit recently vacated and remanded a decision by the Patent Trial and Appeal Board (“Board”) that held the phrase “mechanical control assembly” was not a means-plus-function limitation. The Court found that the Board improperly conflated the two steps of the means-plus-function analysis. In short, the Board erroneously held “that the specification’s disclosure of corresponding structure demonstrates that the alleged means-plus-function term is sufficiently definite so as to not invoke 35 U.S.C. § 112, ¶ 6.” See MTD Prods. Inc. v. Iancu, No. 2017-2292, 2019 U.S. App. LEXIS 23889 (Fed. Cir. Aug. 12, 2019) (Before Reyna, Taranto, and Stoll, Circuit Judges) (Opinion for the Court, Stoll, Circuit Judge).
MTD Products Inc. (“MTD”) is the owner of U.S. Patent No. 8,011,458 (“the ’458 patent”), which is related to zero-turn-radius (“ZTR”) vehicles — for example, lawnmowers. In particular, the ’458 patent describes an improved steering mechanism that allows the vehicle to operate more like an automobile when traveling in forward and reverse. Of particular interest to this appeal was the limitation directed to a “mechanical control assembly.” The claims recited, in part:
a mechanical control assembly coupled to the left and right drive units that is configured to actuate the left and right drive units based on a steering input received from the steering device and a speed input received from the speed control member;
the mechanical control assembly being configured such that if the speed control member is shifted from (a) a forward position in which the left drive wheel is rotating in a forward direction at a first forward speed and the right drive wheel is rotating in a forward direction at a second forward speed that is less than the first forward speed as a result of the steering device being in a first right turn position to (b) a reverse position while the first right turn position of the steering device is maintained, then the left drive wheel will rotate in a reverse direction at a first reverse speed and the right drive wheel will rotate in a reverse direction at a second reverse speed that is less than the first reverse speed.
(emphasis in opinion). The ’458 patent specification did not define a “mechanical control assembly” or even mention the term, but the specification did include a “ZTR control assembly,” which includes “inputs, outputs, and linkages.”
The Toro Company (“Toro”) sought inter partes review (“IPR”) of the ’458 patent, and the Board found the claims to be obvious under § 103. In the decision, the Board construed the term “mechanical control assembly” to fall outside the purview of § 112, ¶ 6, holding that the term was not a means-plus-function term because the specification includes “corresponding structure … with a structural definition for the term.”
During the IPR, MTD argued that the term was a means-plus-function term and that the relevant art did not describe the corresponding structure. MTD’s expert testified that the term is a “nonce” term without a well-known meaning to those of skill in the art. He also described how the term could be used to describe any number of various parts for a vehicle. Toro did not contradict the testimony but argued that a person of skill in the art would read the “ZTR control assembly” found in the specification to be the specific structure for the “mechanical control assembly.” Initially, the Board agreed with MTD that the “genericness” of the term leans in favor of means-plus-function, as the term resembles “mechanism” or “element,” which would invoke § 112, ¶ 6. The Board also held the “configured to” language leaned in favor of means-plus-function.
The Board agreed with Toro, however, that the specification and prosecution history favored not invoking § 112, ¶ 6. First, the Board stated that “[t]he parties agree that the claimed ‘mechanical control assembly’ is referred to in the specification as a ‘ZTR control assembly.’” A person of skill in the art would understand the term “to denote structure because ‘the specification illustrates and describes the specific structure that makes up the ZTR control assembly, and how it connects to and operates with other components.’” Second, the Board found the prosecution history to be persuasive, finding that MTD made assertions that the “mechanical control assembly” is “structurally different” than the prior art and that “the configuration of the mechanical control assembly … is indeed structural” (emphasis omitted). The Board found these statements to be strong evidence that the term was structural rather than a means-plus-function limitation.
The Court first considered the proper means-plus-function analysis. The initial question is whether the claim uses the word “means.” If it does not, there is a rebuttable presumption that the term conveys sufficient structure, and that presumption can be rebutted “by demonstrating ‘that the claim term fails to “recite sufficiently definite structure” or else recites “function without reciting sufficient structure for performing that function.”’” (QuotingWilliamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015).)
One way a challenger can rebut this presumption is to demonstrate how a nonce term operates like the word “means.” Nonce words can include generic terms like “module” that describe a function more than a structure. “[A] critical question is whether ‘the claim term is used in common parlance or by persons of skill in the pertinent art to designate structure,’ including either a particular structure or a class of structures.” (QuotingSkky, Inc. v. MindGeek, s.a.r.l., 859 F.3d 1014, 1019 (Fed. Cir. 2017).) Even if the claims recite a nonce term, other terms or phrases in the claims can help ascertain whether the term recites structure. The term “circuit,” for example, can be construed as a structural term if one or more appropriate identifiers, such as “logic,” identify the circuit. See Apex Inc. v. Raritan Computer, Inc., 325 F.3d 1364, 1372–74 (Fed. Cir. 2003). Alternatively, terms such as “cheque standby unit” can be found to be functional if the term is not “reasonably well understood by persons of ordinary skill in the art to refer to a structure or class of structures.” (CitingDiebold Nixdorf, Inc. v. Int’l Trade Comm’n, 899 F.3d 1291, 1302 (Fed. Cir. 2018).) This is particularly true if a person of skill in the art might define the term to be “any” structure that is capable of performing the function.
Finally, the specification can help provide evidence of whether the term is structural. Although a patentee can be his own “lexicographer,” limitations, including preferred embodiments, should not be imported from the specification to “impart structure.” Even if a single embodiment is disclosed, if the patentee does not express intent to define the term, the single embodiment should not be imported.
In construing “mechanical control assembly,” the Court noted the specification did not define the term. The Court agreed with the Board that the term is more like a nonce term rending it a means-plus-function term. It also agreed with the Board that there is no “established meaning in the art” for the term and that it is instead a generic label. The Court did find error, however, with the Board’s importation of the “ZTR control assembly” as a structural definition of the term. “That the specification discloses a structure corresponding to an asserted means-plus-function claim term does not necessarily mean that the claim term is understood by persons of ordinary skill in the art to connote a specific structure or a class of structures.”
There are two steps to the means-plus-function analysis: first to determine whether the claim follows the means-plus-function format, and second to determine whether the specification identifies a structure that “corresponds” to, or performs, the claimed functions. The Court held that the Board conflated those two steps. The Board held that the structures that perform the means-plus-function provide structure to the term, thus removing the term from the means-plus-function analysis. The Court held that such analysis, i.e., if the specification provides a corresponding structure, as required under § 112, ¶ 6, then § 112, ¶ 6 does not apply, would render § 112, ¶ 6 meaningless.
Finally, the Court considered the Board’s prosecution history analysis, finding that the assertions made during prosecution to merely define the phrase denoted structure instead of “intended use.” The Court then held that the term “mechanical control assembly” was a means-plus-function limitation.
In so holding, the Court vacated the Board’s decision that the claims of the ’458 patent are obvious, as the decision was based on an erroneous construction of the means-plus-function term.
Providing an exemplary structure in the specification that performs a claimed function should not be construed as providing a “sufficiently definite structure” in order to remove the limitation from the purview of § 112, ¶ 6.
233-2. Federal Circuit Is Hesitant to Construe Patent Claims in the First Instance on Appeal; Remands Computer Toolbar Claims to District Court for Further Consideration
The Federal Circuit recently vacated and remanded a decision by the Northern District of California granting a motion on the pleadings that claims related to “toolbars” on computers were ineligible under 35 U.S.C. § 101. The Court, holding that the district court failed to address a claim construction dispute, was “hesitant to construe patent claims in the first instance on appeal” and remanded for further proceedings. Judge Lurie authored a dissent, finding the claims to be “clearly abstract, regardless of claim construction,” and opined that he would have affirmed the district court’s holding. See MyMail, Ltd. v. ooVoo, LLC, Nos. 2018-1758, 2018-1759, 2019 U.S. App. LEXIS 24430 (Fed. Cir. Aug. 16, 2019) (Before Lourie, O’Malley, and Reyna, Circuit Judges) (Opinion for the Court, Reyna, Circuit Judge) (Dissenting opinion, Lourie, Circuit Judge).
MyMail, Ltd. (“MyMail”) is the assignee of U.S. Patent Nos. 8,275,863 (“the ’863 patent”) and 9,021,070 (“the ’070 patent”), which are both directed to toolbars that are displayed on computers. Claim 1 of the ’863 patent, which is representative of the claims for both patents, recites in part:
1. A method of modifying a toolbar, comprising the steps of:
a user Internet device displaying a toolbar comprising one or more buttons, the toolbar defined by toolbar data stored in one or more toolbar-defining databases, the toolbar data comprising a plurality of attributes, each attribute associated with a button of the toolbar, wherein for each button of the toolbar, at least one of the plurality of attributes identifying a function to be performed when the button is actuated by the user Internet device;
…
the user Internet device updating, by the operation, the toolbar data in accordance with the toolbar update data, thereby producing updated toolbar data, the updating comprising at least one of the following steps (a) and (b), each respectively comprising:
(a) writing at least one new attribute to the original toolbar data, wherein the writing at least one new attribute to the toolbar data comprises changing the one or more buttons of the toolbar by adding a button; and
(b) updating at least one attribute of the toolbar data; and the user Internet device displaying the toolbar as defined by the updated toolbar data.
Claim 1 of the ’070 patent recites similar features. In 2016, MyMail filed suit against ooVoo, LLC (“ooVoo”) and IAC Search & Media, Inc. (“IAC”) in the Eastern District of Texas for infringing the two patents. After the Supreme Court decided TC Heartland LLC v. Kraft Foods Group Brands LLC, 137 S. Ct. 1514 (2017), both cases were transferred to the Northern District of California. There, both defendants moved for judgment on the pleadings, asserting that the claims of both patents were ineligible under 35 U.S.C. § 101. MyMail argued that the court should adopt a claim construction for the term “toolbar” from a previous case in the Eastern District of Texas regarding the ’070 patent. The district court, however, did not adopt the claim construction nor did it construe the term at all.
Instead, the district court held that the claims for both patents were patent-ineligible using the two-part framework in Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014). At step 1, the district court found the claims to be “directed to a process for updating toolbar software over a network without user intervention,” which it considered to “fall within the category of gathering and processing information” that is directed to an abstract idea. At step 2, the district court held the claims did not provide an inventive concept as the “Internet-connected computers and servers” recited in the claims were “already in widespread use” and are routine and conventional. To that end, the district court held the claims were ineligible under § 101, and MyMail appealed.
The Court first described the 9th Circuit standard for a Rule 12(c) motion, stating that “[p]atent eligibility may be determined on a Rule 12(c) motion, but only when there are no factual allegations that, if taken as true, prevent resolving the eligibility question as a matter of law.” (Quoting Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, 1125 (Fed. Cir. 2018).) Because “eligibility requires a full understanding of the basic character of the claimed subject matter,” “if the parties raise a claim construction dispute at the Rule 12(c) stage, the district court must either adopt the non-moving party’s constructions or resolve the dispute to whatever extent is needed to conduct the § 101 analysis.”
In the previous Eastern District of Texas case, the district court construed “toolbar” to describe a “button bar that can be dynamically changed or updated via a pinger process or a MOT script.” MyMail argued that this construction “confirms that the claims of the ’070 patent are directed to a particular technological process for improving an exclusively computer-oriented device.” The Northern District of California, however, did not adopt the construction of “toolbar” nor did it decide on any other construction of the term. On appeal, the defendants argued that this error could be dismissed because the remainder of the elements clearly show that the claims were ineligible.
The Court disagreed and held that the Northern District of California’s “failure to address the parties’ claim construction dispute is error under Aatrix.” Seeid. at 1125. Because the Court is “generally hesitant to construe patent claims in the first instance on appeal,” the court vacated and remanded for further proceedings.
In his dissent, Judge Lourie took the position that “the claims at issue are clearly abstract, regardless of claim construction,” and opined that the Court should affirm. Citing Elec. Power Group, LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016), Judge Lourie described how “analysis, transmission, and display of information are, in themselves, abstract ideas.” Because the computers in MyMail’s patents were “off-the-shelf” computers that gathered, sent, and displayed information, the claims are ineligible. He also noted that no “inventive programming” was disclosed in the patents.
As for the “pinger process” and “MOT script” in the Eastern District of Texas’s construction, Judge Lourie stated that these features could not provide the inventive concept necessary to save the claims. MyMail’s appeal brief disclosed how the pinger process consists of programming an off-the-shelf computer to send data. Judge Lourie concluded by asserting that he would not have remanded the case.
If the construction of a claim term is in dispute and the dispute is not addressed by the district court, the Federal Circuit may remand the case for further proceedings even if the challenged claims point strongly in the direction of ineligibility under 35 U.S.C. § 101.
233-3. “Substantially Equivalent” Disclosure May Satisfy Written Description Requirement When Equivalence Relates to Nonlimiting Parameters
The Federal Circuit recently affirmed in part and reversed in part a district court decision holding that Actavis Laboratories FL, Inc.’s (“Actavis’s”) generic Abbreviated New Drug Application (“ANDA”) product infringed claims of patents owned by Nalpropion Pharmaceuticals (“Nalpropion”) and that the asserted claims were not invalid. See Nalpropion Pharms., Inc. v. Actavis Labs. FL, Inc., No. 2018-1221, 2019 U.S. App. LEXIS 24281 (Fed. Cir. Aug. 15, 2019) (Before Prost, Chief Judge, Lourie and Wallach, Circuit Judges) (Opinion for the Court, Lourie, Circuit Judge) (Dissent-in-part, Prost, Chief Judge). The Court found that the district court did not err in finding that Nalpropion’s U.S. Patent No. 8,916,195 (“the ’195 patent”) was not invalid for lack of written description, but that the district court did err in finding that the asserted claims of U.S. Patent Nos. 7,375,111 (“the ’111 patent”) and 7,462,626 (“the ’626 patent”) were not obvious in view of the prior art.
The patents at issue are directed toward weight management in overweight adults via administration of effective amounts of bupropion and naltrexone. Actavis filed an ANDA to sell a generic version of Nalpropion’s product Contrave prior to the expiration of Nalpropion’s patents. Nalpropion brought suit for patent infringement, and Actavis in turn challenged the asserted claim of the ’195 patent as invalid for lack of written description and the asserted claims of the ’111 and ’626 patents as invalid for obviousness. The district court determined that all asserted claims were not invalid and were infringed.
The Federal Circuit agreed that the ’195 patent was not invalid for lack of written description. The asserted claim of the ’195 patent contained language regarding a “dissolution profile of a dissolution test of USP Apparatus 2 Paddle Method.” Actavis argued that the claim lacked adequate written description because the claimed dissolution profile was achieved using the USP Apparatus 2 Paddle Method (“USP 2”), but the specification disclosed data that was obtained using the different USP Apparatus 1 Basket Method (“USP 1”).
The district court concluded on the facts that USP 1 and USP 2 were “substantially equivalent,” and therefore the specification showed that the inventors possessed the invention irrespective of the method of measurement used. The Federal Circuit did not disturb this finding, noting that “‘[t]he test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.’ It is not necessary that the exact terms of a claim be used in haec verba in the specification, and equivalent language may be sufficient.” The Court found that the district court’s findings were supported by the record and so concluded that:
While as a general matter written description may not be satisfied by so-called equivalent disclosure, in this case, buttressed by the district court’s fact-finding, and where the so-called equivalence relates only to resultant dissolution parameters rather than operative claim steps, we affirm the district court’s conclusion. Rigidity should yield to flexible, sensible interpretation.
With respect to the obviousness of the ’111 and ’626 patents, however, the Court disagreed with the district court’s nonobviousness decision. The Federal Circuit reversed, finding that the claims were obvious in light of the prior art, which would have motivated a person of ordinary skill in the art to combine bupropion and naltrexone for weight loss given that both drugs had shown weight loss effects and were administered in combination in the prior art to minimize weight gain.
Chief Judge Prost dissented in part with respect to the majority’s written description determination, stating that the majority appeared to add a “new rule” that “written description for nonlimiting clauses may be satisfied by disclosure that is ‘substantially equivalent’ even though the same disclosure would not be sufficient for limiting clauses.” She argued that the ’195 patent should be found invalid because the claimed use of the USP 2 standard for measuring the dissolution was a limiting clause not disclosed by the specification, which instead disclosed USP 1. Judge Prost noted that there was no record evidence to support that USP 1 and USP 2 were substantially equivalent, and that while teachings relating to USP 1 might render USP 2 obvious, this was not the standard for a sufficient written description. Therefore, Judge Prost found that the majority’s determination did not comport with the law and dissented from the written requirement section of the majority’s opinion.
A “substantially equivalent” disclosure may satisfy the written description requirement when the equivalence relates only to nonlimiting parameters rather than to operative claim steps.
233-4. Federal Circuit Affirms District Court’s Claim Construction of a Coined Term Without Ordinary Meaning in the Industry, Relying on Arguments Made During Prosecution
Recently, the Federal Circuit affirmed the decision of the United States District Court for the Eastern District of Texas, finding that the district court correctly construed the claim term “high quality of service connection” as used in U.S. Patent No. 8,036,119 (“the ’119 patent”), a patent held by Iridescent Networks, Inc. (“Iridescent”). In claim construction, the district court found that “high quality of service connection” means “a connection that assures connection speed of at least approximately one megabit per second, and packet loss requirements that are about 10-5 and latency requirements that are less than one second.” Following the district court’s ruling on claim construction, the parties jointly stipulated to noninfringement by AT&T Mobility, LLC, and Ericsson Inc. (“ATT”). Iridescent appealed on the ground that the district court erred in its construction. See Iridescent Networks, Inc. v. AT&T Mobility, LLC, Ericsson Inc., No. 2018-1449, 2019 U.S. App. LEXIS 23435 (Fed. Cir. Aug. 12, 2019) (Before Prost, Chief Judge, Reyna, and Taranto, Circuit Judges) (Opinion for the Court, Reyna, Circuit Judge).
The ’119 patent, titled “System and Method of Providing Bandwidth on Demand,” describes applications that require high bandwidth on demand such as video calling, multiplayer gaming, telemedicine, etc. These applications are described as being sensitive to delays and packet loss. To provide such applications with the bandwidth they require while minimizing delay (or latency) and reducing packet loss, the invention creates custom network routes for the data flow for a given application.
The controversy began in July 2016, when Iridescent filed a complaint against ATT for infringement of claims 1, 3–4, 7, and 11 of the ’119 patent. During claim construction, the term “high quality of service connection,” as recited in claim 1, was disputed by the parties. Iridescent proposed a broad construction in which the term meant “a connection in which one or more quality of service connection parameters, including bandwidth, latency, and/or packet loss, are assured from end-to-end based on the requirements of the application.” ATT, relying on the prosecution history of a parent application of the ’119 patent, proposed a construction that required a “connection speed of at least approximately one megabit per second, and where applicable based on the type of application, packet loss requirements that are about 10-5 and latency requirements that are less than one second.” After both the magistrate and district court judges sided with ATT’s construction, Iridescent and ATT jointly stipulated to ATT’s noninfringement, and the district court entered a judgment against Iridescent on December 18, 2017.
Iridescent then appealed on the basis that the district court erred in its construction of “high quality of service connection.” Before the Federal Circuit, Iridescent argued that “high quality of service connection” should be construed as a requirement that the provided network connection assure the level of quality that meets the needs of a particular application. To support its construction, Iridescent raised three primary arguments.
Iridescent first argued that the term serves to distinguish the invention from prior art systems, which utilized “best effort” connections in which data packets are transmitted in an unpredictable and ad hoc manner. The Federal Circuit found this argument contradicted the written description of the ’119 patent. Specifically, the Federal Circuit found that Figure 3 and its associated description did not support such a construction because it did not identify the “Ojo Video Call Application” — which had requirements of less than 1 megabit per second in bandwidth, packet loss of 10-5, and latency of less than 400 milliseconds — as “high QoS (quality of service).” The Federal Circuit found that this exclusion, coupled with statements made during prosecution of the parent application in which Iridescent argued that “high QoS may be viewed in the present application as having speeds varying from approximately 1-300 megabits per second, packet loss requirements that are typically about 10-5, and latency requirements that are typically less than one second,” weighed against the term merely serving to distinguish the prior art “best effort” connections.
Iridescent then argued that the prosecution history should be irrelevant to claim construction because there was no clear and unmistakable disavowal of claim scope. The Federal Circuit found that, while such disavowal may be required in order to limit the scope of a claim term with ordinary and customary meaning, the term “high quality of service connection” is a coined term. Accordingly, the district court was free to look to the prosecution history for guidance on the term’s meaning without having to first find a clear and unmistakable disavowal.
Iridescent’s third argument was that the relied-upon prosecution history should be irrelevant because it involved statements made in response to an enablement rejection. Iridescent attempted to liken enablement rejections to indefiniteness rejections, but the Federal Circuit found such a comparison was inappropriate. The Federal Circuit reiterated that “enablement serves the dual function in the patent system of ensuring adequate disclosure of the claimed invention and of preventing claims broader than the disclosed invention.” MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1380–81 (Fed. Cir. 2012) (internal citation omitted). Therefore, the Federal Circuit ruled that the statements made to overcome the enablement rejection are relevant to inform the scope of the disputed claim term.
Regarding Iridescent’s remaining arguments, the Federal Circuit summarily stated they were unpersuasive. Ultimately, the Federal Circuit held that, given that “high quality of service connection” was a coined term and in light of the statements made in the prosecution history, the correct construction was “a connection that assures connection speed of at least approximately one megabit per second and, where applicable based on the type of application, packet loss requirements that are about 10-5 and latency requirements that are less than one second.”
Accordingly, the Federal Circuit affirmed the district court’s decision.
For claim construction purposes, the use of coined terms allows courts more leeway in looking to the prosecution history in order to understand the meaning of the terms. Further, simply using ordinary words, such as “high” and “quality,” may not be sufficient to establish ordinary and customary meaning in the art.
233-5. Federal Circuit Vacates on Constitutional Grounds District Court’s Invalidity Decision on Disclaimed Claims
The Federal Circuit recently issued an opinion vacating in part and affirming in part a decision of the District Court of New Jersey implicating U.S. Patent No. 8,927,592 (“the ’592 patent”) and U.S. Patent No. 5,847,170 (“the ’170 patent”) owned by Sanofi Aventis U.S., LLC, Sanofi Mature IP, and Sanofi (collectively, “Sanofi”). Specifically, the Court vacated the decision that claims of the ’592 patent were invalid because, under Article III of the Constitution, no case or controversy existed over the statutorily disclaimed claims. On the other hand, the Court affirmed the decision that claims of the ’170 patent were not obvious. Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc., No. 18-1221, 2019 U.S. App. LEXIS 24141 (Fed. Cir. Aug. 14, 2019) (Before Lourie, Moore, and Taranto, Circuit Judges) (Opinion for the Court, Lourie, Circuit Judge).
The ’170 and ’592 patents respectively claim the compound cabazitaxel and methods of using it, which Sanofi markets to treat certain drug-resistant prostate cancers. After Fresenius and other defendant-appellees (collectively, “Defendants”) filed ANDAs to market generic versions of cabazitaxel, Sanofi sued for infringement in the District of New Jersey, and Defendants counterclaimed for a declaratory judgment of invalidity of the ’592 patent. While this case was pending, the Patent Trial and Appeal Board (the “Board”) instituted inter partes review of the ’592 patent, held certain claims unpatentable as obvious, and denied Sanofi’s motion to amend the claims. Without appealing the Board’s invalidity decision, Sanofi filed a statutory disclaimer of the relevant claims. Shortly thereafter, the district court held that (1) despite the statutory disclaimer, a case or controversy still existed regarding the disclaimed claims and that these were invalid as obvious, and (2) certain ’170 patent claims were not obvious. Both parties appealed. The Federal Circuit, first, vacated the district court’s judgment regarding the disclaimed claims, holding that no case or controversy existed over these claims and that, therefore, the court lacked authority to declare them invalid. Second, the Court affirmed the district court’s finding of nonobviousness regarding the ’170 patent claims.
No case or controversy existed regarding the validity of the disclaimed claims of the ’592 patent because Sanofi’s disclaimer of the claims mooted any controversy over them. “To have standing, a plaintiff must present an injury that is concrete, particularized, and actual or imminent; fairly traceable to the defendant’s challenged behavior; and likely to be redressed by a favorable ruling.” Furthermore, as the Court emphasized, “an actual controversy must be extant at all stages of review, not merely at the time the complaint is filed.” Sanofi’s disclaimer effectively eliminated the claims from the patent “as though the disclaimed claims never existed.” Any infringement-based dispute was therefore mooted. When the court entered final judgment, the requested relief was both speculative and immaterial to possible future defenses.
The Court rejected the Defendants’ argument that its vacatur of the judgment eliminated the possible benefit of an issue preclusion defense if Sanofi were to obtain amended claims and assert them against the Defendants. First, the relevance of the disclaimed claims to a possible preclusion defense was speculative — when the final judgment was issued, the Board had denied Sanofi’s motion to amend the claims, and no amended claims existed. Second, Defendants failed to show that the final judgment was relevant to their potential issue preclusion arguments. Because no case or controversy existed, the court had no authority to declare the disclaimed claims invalid.
Next, following a fact-heavy inquiry, the Court concluded that claims 1 and 2 of the ’170 patent would not have been obvious over docetaxel, the lead compound and prior art. “[I]n cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound.” However, “[a]ny compound may look obvious once someone has made it and found it to be useful, but working backwards from that compound, with the benefit of hindsight, once one is aware of it does not render it obvious.” The Court specifically considered whether a skilled artisan would have been motivated to replace the C7 and C10 hydroxyl groups of docetaxel, which a person of ordinary skill would have selected as a lead compound, with the methoxy groups of cabazitaxel. The Court concluded that a skilled artisan would not have been motivated to do so. Defendants’ arguments amounted to nothing more than hindsight.
Statutorily disclaiming claims moots any infringement-based controversy over them and renders the district court without authority to issue judgments over the disclaimed claims.
233-6. The Federal Circuit Finds the Lower Court Applied an Overly Restrictive Interpretation of the Relation Back Doctrine in Finding Anza’s Claims Time-Barred
Recently, the Federal Circuit reversed, vacated, and remanded a decision of the U.S. District Court for the District of Colorado that granted Mushkin, Inc.’s (“Mushkin’s”) motion to dismiss Anza Tech.’s (“Anza”) complaint seeking damages for alleged patent infringement occurring between March 2011 and April 2012 because the claim for damages was time-barred by the six-year statute of limitations in the Patent Act, 35 U.S.C. § 286. See Anza Tech., Inc. v. Mushkin, Inc., No. 2019-1045, 2019 U.S. App. LEXIS 24432 (Fed. Cir. Aug. 16, 2019) (Before Prost, Chief Judge, Newman and Bryson, Circuit Judges) (Opinion for the Court, Bryson, Circuit Judge).
The controversy began in March 2017 when Anza filed suit against Mushkin in the U.S. District Court for the Eastern District of California, alleging that Mushkin infringed claims 1, 14, and 16 of Anza’s U.S. Patent No. 7,124,927 (“the ’927 patent”). On September 6, 2017, Anza filed its first amended complaint, which joined Avant Technology, Inc., as a co-defendant. Thereafter, the California district court granted Mushkin’s motion to sever Anza’s claims against Mushkin and transfer the case to the District of Colorado. Next, Anza, while engaging in mediation with Mushkin, conceded that its claims were no longer viable, which led to Anza filing a second amended complaint in June 2018 with the court’s permission.
In Anza’s second amended complaint, Anza removed the infringement allegations regarding the ’927 patent and alleged infringement of two new patents: U.S. Patent Nos. 6,354,479 (“the ’479 patent”) and 6,651,864 (“the ’864 patent”). Anza also omitted 10 of the 16 products that had been accused in the original complaint and added two new products that had not previously been accused. The district court granted Mushkin’s motion to dismiss because the claims in Anza’s second amended complaint did not relate back to the date of Anza’s original complaint. Further, because Anza acknowledged that Mushkin’s allegedly infringing activity took place more than six years before the filing date of the second amended complaint, all the asserted claims in the second amended complaint were time-barred.
Under Rule 15(c)(1)(B) of the Federal Rules of Civil Procedure, “[a]n amendment to a pleading relates back to the date of the original pleading when … the amendment asserts a claim or defense that arose out of the conduct, transaction, or occurrence set out — or attempted to be set out — in the original pleading.” The district court found that, “[a]lthough the claims involve the same parties, they do not relate to identical products and technology.” Comparing the ’864 and ’479 patents with the ’927 patent, the district court found that the asserted claims of the ’864 and ’479 patents “protect a method of using a wire bonding tool, while the ’927 claims involved a flip chip bonding and solder ball placement tool.” The district court acknowledged that the patent claims have the “same purpose — bonding integrated circuit chips to printed circuit boards while minimizing electrostatic discharge.” But because it found that “different processes and technologies are used to achieve this purpose,” the district court held that the patent claims were “not part and parcel of one another.”
In its determination of whether newly alleged claims, based on separate patents, relate back to the date of the original complaint, the Federal Circuit considered (1) the overlap of parties, (2) the overlap in the accused products, (3) the underlying science and technology, (4) time periods, and (5) any additional factors that might suggest a commonality or lack of commonality between the two sets of claims.
Of course, the overlap of the parties existed with Anza and Mushkin both being original parties in the suit. As mentioned above, the overlap of the accused products included six products in the second amended complaint from the original complaint. Regarding the underlying science and technology, the Federal Circuit found that the three patents focused on solving the same problem by the same solution, using a bonding tool tip made of a dissipative material having a resistance low enough to prevent the discharge of a charge to a device being bonded and high enough to avoid current flow to that device. With respect to the time periods, the Court determined there was no lack of notice and no substantial prejudice to Mushkin from having to defend against independent claims over a shorter period than the period set forth in the original complaint (the original complaint included the six-year period before March 2017, while the second amended complaint alleged damages occurring between March 2011 and April 1, 2012).
Accordingly, the Federal Circuit reversed the dismissal of the claims regarding the six overlapping products, finding that those products related back to the date of the original complaint. Regarding the two newly added products, the Federal Circuit vacated the order of dismissal and remanded for the district court to determine whether the allegations regarding those products relate back to the filing date of the original complaint.
In determining whether newly alleged claims, based on separate patents, relate back to the date of the original complaint, a nonexhaustive list of factors includes (1) the overlap of parties, (2) the overlap in the accused products, (3) the underlying science and technology, (4) time periods, and (5) any additional factors that might suggest a commonality or lack of commonality between the two sets of claims.
233-7. No Grounds to Reverse Expert’s Claim-Construction Testimony Because No Objection Was Made; Companion Case Denies Attorney Fees for “Disproportionate Trial”
The Federal Circuit recently affirmed in part and reversed in part the Central District of California’s denial of judgment as a matter of law (“JMOL”) related to invalidity and noninfringement of patent claims. The Court reversed the denial with respect to invalidity, finding that the expert’s testimony on predating the critical date provided a reference’s year but no date. The Court then affirmed the denial with respect to noninfringement even though the jury may have relied on the expert’s testimony on claim construction. The plaintiff failed to object to the testimony, providing no grounds for reversal. See ATEN Int’l Co. v. Uniclass Tech. Co., No. 2018-1606, 2019 U.S. App. LEXIS 23434 (Fed. Cir. Aug. 6, 2019) (Before Moore, Wallach, and Taranto, Circuit Judges) (Opinion for the Court, Moore, Circuit Judge). In another case released the same day, the Court affirmed the denial of attorney fees because of plaintiff’s motivations beyond monetary damages in pursuing litigation. See ATEN Int’l Co. v. Uniclass Tech. Co., No. 2018-1922, 2019 U.S. App. LEXIS 23432 (Fed. Cir. Aug. 6, 2019). (Before Moore, Wallach, and Taranto, Circuit Judges) (Opinion for the Court, Moore, Circuit Judge).
ATEN International Co., Ltd. (“ATEN”) makes and sells keyboard-video-mouse (“KVM”) switch systems, which allows a single keyboard, video monitor, and mouse combination to control multiple computers. ATEN sued Uniclass Technology Co., Ltd. (“Uniclass”) and six other defendants in the Central District of California for infringing claims of two patents related to KVM switches. U.S. Patent No. 8,589,141 (“the ’141 patent”) is directed specifically to KVM switches and describes “[a] method for controlling a resource sharing apparatus coupling at least one input device to a plurality of hosts including a first host.” U.S. Patent No. 7,640,289 (“the ’289 patent”) is directed to a system for connecting multiple KVM switches and determining which switch is a “master” or “slave.” A jury found the ’141 patent to be invalid and not infringed and found the ’289 patent not infringed. ATEN moved for JMOL, which was denied, and ATEN subsequently appealed.
The Court first considered the validity of the ’141 patent. At trial, Uniclass proffered two theories of invalidity: first, that the claims were anticipated by ATEN’s previous switch CS-1762, and second, that the claims were anticipated by Great Britain Patent No. 2,352,540 (“GB ’540”). There was no special verdict, so the Court could not ascertain what the jury considered as the invalidating art. Accordingly, the Court addressed both references.
For ATEN’s product CS-1762, the Court first acknowledged the critical date for the ’141 patent, which was July 24, 2006. Uniclass based the anticipation theory on a 2009 CS-1762 specimen. Their expert used the Wayback Machine to determine that the 2009 specimen was running on firmware from 2006. The witness did not, however, testify as to when in 2006 the CS-1762 was running on the firmware. A proponent must “prove by clear and convincing evidence” that the reference predates the patent in suit. The Court acknowledged that the deposition testimony did not provide a specific date in 2006, and at trial this failure was noted in cross-examination of the witness. Because no date was provided, the Court held that substantial evidence did not support the denial of JMOL.
For patent reference GB ’540, the Court noted the failure of Uniclass to provide nonconclusory evidence for anticipation of “each and every element” in the ’141 patent claims. The claims required the element “emulating the input device to the first host.” Uniclass’s expert concluded that GB ’540 “has USB device emulators in it,” but he did not describe how it emulated the input “to the host.” Accordingly, the Court reversed the district court’s JMOL denial based on invalidity.
The Court then considered the jury’s noninfringement findings for both the ’141 patent and the ’289 patent. ATEN argued that “the jury was confused due to Uniclass’ expert … testimony on the scope of the claim terms.” To describe how Uniclass’s devices did not “connect the input device to the host computer,” as claimed in the ’141 patent, the expert testified:
I look at the prosecution history to understand what ATEN … was telling the patent office… . In this case one of the statements they made to the examiner was the applicant’s invention … has a fundamental difference in comparison to the teaching of [a reference] with regard to the concepts of connected and disconnected between the input device and the host devices.
For the ’289 patent, the expert again described how Uniclass’s devices did not detect “whether the first port is occupied,” as claimed in the patent, by asserting:
[T]he connector is occupied in the [reference], but notice there is no discussion of messages… . In fact, … the [reference] does meet the messages test. So it has to be a determination based on the connector itself actually having a plug in it.
In both cases, the expert looked to the prosecution history to construe the terms. “It is beyond dispute that claim construction issues are to be decided by the court. It is thus improper for an expert witness to testify before the jury regarding claim construction.”
This would be grounds for reversal. However, ATEN did not object to the testimony at trial. The only objection to the expert’s testimony came after the close of evidence when ATEN orally moved for a “post-testifying Daubert on [the expert] testimony on invalidity with respect to anything that required an ATEN claim construction.” The Court held that there were no grounds for reversal because ATEN did not object to the testimony. “It is the parties’ obligation to raise a dispute regarding the proper scope of claims to the court.” (Quoting O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008).)
In so holding, the Court reversed the denial of JMOL as to invalidity of the ’141 patent claims but affirmed the denial as to noninfringement of both patents.
An expert witness should not testify on claim construction. However, if the opponent of the testimony does not object, there are no grounds for reversal based on the testimony.
CASE ON ATTORNEY FEES
In a similar case decided the same day, the Court considered Uniclass and the other defendants’ motion for attorney fees, which the district court had denied.
In the case described above, ATEN first argued for lost profits, which the district court denied at summary judgment. ATEN then proceeded under a theory of reasonable royalties, estimated to be $678,337.
After trial, Uniclass moved to declare the case exceptional by arguing that “ATEN did not conduct an adequate pre-filing investigation, unnecessarily increased the costs of claim construction, drastically increased discovery costs by frequently changing counsel and infringement positions, and engaged in unreasonable litigation behavior requiring additional motion practice and leading to an expensive and disproportionate trial.”
The Court reviews denial of attorney fees for abuse of discretion, which may be shown if the district court “based its ruling on an erroneous view of the law or on a clearly erroneous assessment of the evidence.”
Uniclass based its argument on two theories: (1) proportionate litigation and (2) frivolity of ATEN’s damages analysis. As for the proportionate litigation theory, Uniclass pointed to the large expenditures during the case with a maximum recovery of $678,337. Expert fees alone ran over $700,000. However, “[t]here is no per se rule that a case is exceptional if litigation costs exceed the potential damages.” The Court noted that damages are only one motivation for lawsuits. This is particularly true if the two parties are competitors, as was the case here. Additionally, ATEN sought an injunction, which does not include any monetary damages, and the case could have gone to trial with respect to the injunction alone.
As for the frivolity argument, Uniclass argued the district court should have considered the “frivolous damages methodology” in its lost-profits arguments. “Though ATEN’s lost profits theory was not strong enough to withstand summary judgment, ‘[a] party’s position … ultimately need not be correct for them to not “stand[ ] out.”’” (Quoting SFA Sys., LLC v. Newegg Inc., 793 F.3d 1344, 1348 (Fed. Cir. 2015).)
The Court ultimately held that the district court did not abuse its discretion in finding that the case was “not so objectively unreasonable or exceptionally meritless as to stand out from other cases,” and the Court affirmed the district court’s denial of attorney fees.
Litigation costs that are disproportionate to possible monetary recovery do not on their own equate to “objectively unreasonable” litigation. Motivations other than monetary damages exist for litigation.
233-8. The Federal Circuit Upholds the ITC’s Decision Regarding Validity and Infringement of Claims Related to Genetically Engineered E. Coli Bacteria
Recently, the Federal Circuit affirmed the decision of the International Trade Commission (“Commission”) finding certain products produced by CJ CheilJedang Corp., CJ America, Inc., and PT CheilJedang Indonesia (collectively, “CJ”) infringed Ajinomoto’s U.S. Patent No. 7,666,655 (“the ’655 patent”), but that two of its earlier products did not. The Commission also found that the relevant claim of the ’655 patent is not invalid for lack of an adequate written description. In particular, CJ used several strains of Escherichia coli bacteria to produce L-tryptophan products, which it then imported into the United States. Ajinomoto appealed the Commission’s claim construction underlying the determination of noninfringement, and CJ cross-appealed aspects of the determination of infringement by the later strains and the rejection of the invalidity challenge. See Ajinomoto Co. v. ITC, Nos. 2018-1590, 2018-1629, 2019 U.S. App. LEXIS 23435 (Fed. Cir. Aug. 6, 2019) (Before Dyk, Moore, and Taranto, Circuit Judges) (Opinion for the Court, Taranto, Circuit Judge).
The ’655 patent claims genetically engineered E. coli bacteria, whose production of aromatic L-amino acids, such as L-tryptophan, are increased during fermentation, and also claims methods of producing aromatic L-amino acids using such bacteria. Particularly, the ’655 patent identifies a specific gene in the E. coli genome, the yddG gene, that encodes a membrane protein, the YddG protein. When yddG gene activity in bacteria is enhanced so that more YddG protein is produced, the bacteria show increased production of, and increased resistance to, aromatic L-amino acids. The ’655 patent teaches three ways to enhance the activity of the yddG gene: (1) plasmids containing additional copies of the yddG gene can be introduced into the bacterium; (2) additional copies of the yddG gene can be inserted into the bacterial chromosome; and (3) a stronger “promoter” than the one native to the E. coli yddG gene can be used.
The controversy began in May 2016 when Ajinomoto filed a complaint against CJ with the Commission alleging CJ violated 19 U.S.C. § 1337(a)(1)(B)(ii) by importing animal-feed-grade L-tryptophan products produced by a process covered by the ’655 patent. The proceeding focused on three groups of E. coli strains that CJ has used to produce tryptophan. First, CJ’s “earlier strains” contained both the native E. coli yddG gene and the native E. coli yddG promoter, except that the first nucleotide of the promoter was changed through chemical mutagenesis, resulting in a stronger promoter. Second, in November 2016, several months after Ajinomoto filed its complaint, CJ began using its first “later strain,” which contained two copies of a yddG gene: (1) the native E. coli yddG gene with the native E. coli yddG promoter and (2) a non-E. coli yddG gene with two promoters — (2a) a native non-E. coli yddG promoter and (2b) an rmf promoter. Third, in December 2016, CJ started using its second “later strain,” which also contained two copies of a yddG gene: (1) the native E. coli yddG gene with the native E. coli yddG promoter and (2) a codon-randomized non-E. coli yddG gene with two promoters — (2a) an rmf promoter and (2b) an rhtB promoter.
In December 2017, the Commission issued its decision. It affirmed the earlier administrative law judge’s (“ALJ’s”) construction of “replacing the native promoter ... with a more potent promoter” and affirmed the ALJ’s finding that CJ’s earlier strains did not infringe. The Commission, however, reversed the ALJ’s finding with respect to the two later strains and found that both of CJ’s later strains met all disputed claim limitations and thus infringed claim 20, and that claim 20 was not proved to lack an adequate written description.
Before the Federal Circuit, Ajinomoto argued that the claim construction should not be limited to removing the entire native promoter and inserting a new promoter, as the Commission concluded, but should also encompass mutagenesis of individual nucleotides within the native promoter. Based, at least in part, on the ordinary and customary meaning of the claim language, the Federal Circuit determined the Commission’s claim construction was proper because the term “replacing the native promoter ... with a more potent promoter” suggests, in ordinary parlance, an operation at the level of the entire promoter as a unit, not at the level of a single nucleotide that is just one small component of the promoter. The Federal Circuit further determined the specification gave support for the claim construction. In particular, the specification states that “the enhancement of gene expression can be achieved by locating the DNA of the present invention under control of [a] more potent promoter instead of the native promoter.” The ’655 patent, col. 6, lines 12–15.
Finally, the Federal Circuit found that the prosecution history supported the claim construction. More specifically, the examiner rejected claim 2 of the original application — which recited “[t]he bacterium according to claim 1, wherein said activities of proteins ... is enhanced by transformation of said bacterium with DNA coding for the protein ... or by alteration of [the] expression regulation sequence of said DNA on the chromosome of the bacterium” — for lack of an adequate written description and lack of enablement. In response to the rejections, the applicants amended the claim to recite “replacing the native promoter that precedes a DNA encoding said protein ... with a more potent promoter.” Therefore, the Federal Circuit determined that when a word is changed during prosecution, the change tends to suggest that the new word differs in meaning in some way from the original word.
Based on an amendment to the original claims during prosecution, CJ asserted that the prosecution history estoppel barred Ajinomoto from relying on the doctrine of equivalents to meet the protein limitation. Separately, CJ asserted that the non-E. coli YddG protein of CJ’s second later strain could not reasonably be found to be an equivalent of the claimed E. coli YddG protein under the function-way-result test for equivalence. The Supreme Court has specified three ways the patentee can rebut a presumption of general disclaimer of territory between the original claim and the amended claim surrendered during prosecution: (1) “[t]he equivalent may have been unforeseeable at the time of the application”; (2) “the rationale underlying the amendment may bear no more than a tangential relation to the equivalent in question”; and (3) “there may be some other reason suggesting that the patentee could not reasonably be expected to have described the insubstantial substitute in question.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 740 (2002). Here, at issue was whether the Commission erred in its application of the tangential relation rule (No. 2 above). A proper application of the tangential relation rule asks “whether the reason for the narrowing amendment was peripheral, or not directly relevant, to the alleged equivalent.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1369 (Fed. Cir. 2003). The Federal Circuit found that the reason for the amendment had nothing to do with choosing from among several DNA sequences in the redundant genetic code that correspond to the same protein. Therefore, the tangential rule was applicable, and thus the presumption of prosecution history estoppel was rebutted.
Regarding CJ’s challenge of infringement based on Ajinomoto’s assertion of the doctrine of equivalents, the Federal Circuit agreed with evidence presented by Ajinomoto demonstrating equivalence under the function-way-result framework — i.e., a claimed limitation performs substantially the same function in substantially the same way to obtain the same result.
CJ further challenged the Commission’s finding that CJ’s later strains met the resistance limitation. The Federal Circuit dismissed this argument based on several pieces of evidence, including Table 1 of the ’655 patent and CJ’s fermentation data, that indicated enhancing the activity of the YddG protein increases the bacteria’s resistance to L-tryptophan. Finally, CJ argued against the Commission’s validity finding, asserting that substantial evidence did not support the Commission’s finding that CJ did not prove lack of an adequate written description for the genus of “more potent promoter[s]” recited in claims 9 and 15 and, by incorporation, in claim 20. The Federal Circuit agreed with the Commission’s finding that the ’655 patent discloses a representative number of species of more potent promoters and that there are structural features common to the genus of more potent promoters.
Accordingly, the Federal Circuit affirmed the Commission’s decision.
Judge Dyk concurred with the entirety of the decision except the majority’s finding that Ajinomoto successfully rebutted prosecution history estoppel under the tangential relation rule. Judge Dyk reasoned that the anticipating prior art disclosed E. coli YfiK protein, encoded by the YfiK gene, and this prior art was avoided by narrowing the claim to cover only certain encoding nucleotide sequences. Therefore, that rationale was directly related to the accused equivalent, which does not infringe because it does not use a covered encoding nucleotide sequence. Consequently, Judge Dyk viewed the tangential relation rule as inapplicable to the instant case.
For claim construction purposes, changing a term to a similar term during prosecution is an indication that there is a material difference between the terms. A presumption of prosecution history estoppel may be successfully rebutted when an amendment during prosecution is peripheral or unrelated to avoiding an equivalent.
233-9. Federal Circuit Applies Tangential Exception to Prosecution History Estoppel to Affirm Infringement Under the Doctrine of Equivalents
The Federal Circuit affirmed in part and reversed in part the district court’s finding of infringement in the Hospira Decisionand affirmed the district court’s finding of infringement in the Dr. Reddy’s Laboratories decision (“DRL Decision”). The Court found that prosecution history estoppel and the disclosure-dedication rule did not apply to bar Lilly’s claim of infringement against Hospira and DRL under the doctrine of equivalents because Lilly’s amendment during prosecution was only tangential to pemetrexed ditromethamine and therefore did not relinquish any claim scope, and the reference relied on by Lilly did not disclose pemetrexed ditromethamine. See Eli Lilly & Co. v. Hospira, Inc., Nos. 2018-2126, 2018-2127 (“Hospira Decision”), Eli Lilly & Co. v. Dr. Reddy’s Labs., Ltd., No. 2018-2128, 2019 U.S. App. LEXIS 23753 (Before Lourie, Moore, Taranto, Circuit Judges) (Opinion for the Court, Lourie, Circuit Judge).
Lilly filed suit against Hospira and DRL in the Southern District of Indiana for infringement of U.S. Patent No. 7,772,209 (“the ʼ209 patent”) under the Hatch-Waxman Act. The ʼ209 patent claims an improved method of treating non-small cell lung cancer and mesothelioma by administering pemetrexed disodium, an antifolate, through supplementation with a methylmalonic acid-lowering agent such as vitamin B12 and folic acid. Antifolates such as pemetrexed disodium are known to slow or inhibit cell growth and division and therefore are effective in treating cancer. However, they are known to have toxic effects when administered by themselves. Administering pemetrexed disodium along with a methylmalonic acid-lowering agent and folic acid reduces the toxic effect of antifolates such as pemetrexed disodium without sacrificing efficacy.
The ʼ209 patent lists preferred antifolates, including over 50 antifolates described in the Akimoto patent licensed by Lilly, but specifies that pemetrexed disodium is the “most preferred.” The ʼ209 patent originally claimed administering an antifolate in conjunction with a methylmalonic acid-lowering agent with or without folic acid. During prosecution, Lilly amended the claims to narrow “an antifolate” to “pemetrexed disodium.” Hospira and DRL both submitted a New Drug Application for administration of a different antifolate — pemetrexed ditromethamine — in conjunction with a methylmalonic acid-lowering agent and folic acid.
The district court found that Hospira infringed the ʼ209 patent both literally and under the doctrine of equivalents. In so holding, the district court found that prosecution history estoppel did not bar Lilly’s claim because the reason for Lilly’s narrowing amendment during prosecution was to distinguish antifolates generally and therefore was only tangential to the specific antifolate used by Hospira and DRL. The district court also rejected the argument that Lilly dedicated pemetrexed ditromethamine to the public under the disclosure-dedication rule by referencing the more than 50 antifolate compounds identified in the Akimoto patent. The district court issued orders prohibiting FDA approval of the products at issue until the ʼ209 patent expires in both cases. Hospira and DRL filed this consolidated appeal.
The Court first reversed the district court’s finding of literal infringement in the Hospira Decisionbased on its claim construction of “administration of pemetrexed disodium.” In the DRL Decision, the district court construed the phrase “administration of pemetrexed disodium” to mean “liquid administration of pemetrexed disodium,” which “is accomplished by dissolving the solid compound pemetrexed disodium into solution.” The Court held that Hospira did not literally infringe the ʼ209 patent because “to literally practice the ‘administration of pemetrexed disodium’ step under the district court’s claim construction, the pemetrexed disodium salt must be itself administered.” Because Hospira’s treatment involved the administration of pemetrexed ditromethamine, not pemetrexed disodium, there was no literal infringement.
The Court next affirmed the district court’s finding of infringement under the doctrine of equivalents in both the Hospira and DRL decisions. The main issue before the Court was whether Lilly’s narrowing amendment of “an antifolate” to “pemetrexed disodium” during prosecution surrendered all equivalents of pemetrexed disodium, including pemetrexed ditromethamine, under the doctrine of prosecution history estoppel. On appeal, Lilly argued that it did not because the amendment was only tangential to pemetrexed ditromethamine and therefore fell within the tangential exception to prosecution history estoppel. The tangential exception precludes the application of prosecution history estoppel if the narrowing amendment “[bears] no more than a tangential relation to the equivalent in question.” Hospira and DRL argued that the tangential exception did not apply to Lilly’s narrowing amendment because “Lilly failed to explain why it did not pursue a narrower amendment literally encompassing pemetrexed ditromethamine.”
The district court held that the tangential exception applied because “the reason for its amendment was to distinguish pemetrexed from antifolates generally and that the different salt type [disodium versus ditromethamine] is a merely tangential change with no consequence for pemetrexed’s administration.” The Court agreed, holding that “Lilly’s amendment was merely tangential to pemetrexed ditromethamine because the prosecution history, in view of the ʼ209 patent itself, strongly indicates that the reason for the amendment was not to cede other, functionally identical, pemetrexed salts” such as pemetrexed ditromethamine but was rather to distinguish the prior art which disclosed using methotrexate, a different antifolate, and to “more accurately define what it actually invented, an improved method of administering pemetrexed.”
The Court also agreed with the district court that the disclosure-dedication rule — which holds that subject matter disclosed by a patentee but not claimed is dedicated to the public — did not apply to bar Lilly from asserting infringement under the doctrine of equivalents. At the district court and on appeal, DRL argued that Lilly dedicated pemetrexed ditromethamine to the public because one of the references cited by Lilly in the ʼ209 patent, Akimoto, identified preferred antifolates, one of which was pemetrexed ditromethamine, and Lilly declined to claim it in the ʼ209 patent. The district court held that Lilly did not dedicate pemetrexed ditromethamine to the public because Akimoto was not incorporated by reference in the ʼ209 patent and Akimoto did not specifically disclose pemetrexed ditromethamine. The Federal Circuit agreed, holding that “the disclosure-dedication rule is inapplicable to this case because the ʼ209 patent does not disclose methods of treatment using pemetrexed ditromethamine, and, as a result, Lilly could not have dedicated such a method to the public.” The Court emphasized that Akimoto disclosed thousands of compounds, including 50 “exemplary compounds,” none of which were pemetrexed. At most, Akimoto contained only a “generic reference” to pemetrexed ditromethamine, which was not sufficient to find that it was dedicated to the public.
Nevertheless, the Court held that Hospira and DRL infringed under the doctrine of equivalents because Hospira’s and DRL’s “product will accomplish an identical aim, furnishing the same amount of pemetrexed to active sides in the body; in exactly the same way, but diluting a pemetrexed salt in an aqueous solution for intravenous administration. Indeed, after dilution and immediately before administration,” Hospira’s and DRL’s “product is functionally identical to Lilly’s in that it contains the same amount of diluted pemetrexed anion.”
The tangential exception to prosecution history estoppel is very narrow, and generally, “an amendment that narrows an existing claim element evinces an intention to relinquish that claim scope.” For the tangential exception to apply, the patent owner must show that the surrendered claim scope was “peripheral, or not directly relevant” to its amendment. Application of the tangential exception must be determined by “reference to the context in which [the narrowing amendment] was made, including the prior art that might have given rise to the amendment in the first place.” Further, the disclosure-dedication rule will not apply if the patent at issue contains only a generic, rather than an express, reference to the supposedly dedicated subject matter.